AbbVie's ABT-494 Meets Primary Endpoint in Two Phase 2 Studies in Rheumatoid Arthritis

- Potential for best-in-class therapy with an overall favorable safety profile

- The primary endpoint of both studies was ACR20 response at week 12

- In the TNF-inadequate responder population, ACR20 responses up to 73 percent and ACR50 responses up to 44 percent

- In the MTX-inadequate responder population, ACR20 responses up to 82 percent and ACR50 responses up to 50 percent

- AbbVie intends to move rapidly to Phase 3 studies of ABT-494 by the end of 2015 with a once-daily formulation

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Sep 25, 2015, 07:12 ET

NORTH CHICAGO, Ill., Sept. 25, 2015 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global biopharmaceutical company, today announced results from two Phase 2 clinical trials evaluating its investigational selective JAK1 inhibitor, ABT-494, in patients with inadequate response to either methotrexate or TNF inhibitors. The clinical trials, BALANCE-I and BALANCE-II, achieved ACR20 at week 12 across all dose levels, except the lowest dose in BALANCE-II. BALANCE-I and BALANCE-II evaluated patients with moderate to severe rheumatoid arthritis with inadequate responses to prior anti-TNF (TNF-IR) or methotrexate (MTX-IR) treatment, respectively.

"We believe ABT-494 has the potential to become a best-in-class therapy, particularly in the most challenging patient population of TNF-inadequate responders," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We are encouraged by the results of our Phase 2 studies and we will advance ABT-494 to Phase 3 studies with a once-daily formulation."

BALANCE – I (TNF-IR)	ACR20	ACR50	ACR70	BALANCE – II (MTX-IR)	ACR20	ACR50	ACR70
3 mg, twice-daily	56%^*	24%	13%	3 mg, twice-daily	65%	40%^*	23%^*
6 mg, twice-daily	63%^**	37%^*	27%^***	6 mg, twice-daily	73%^*	49%^**	31%^**
12 mg, twice-daily	73%^***	44%^**	22%^**	12 mg, twice-daily	82%^**	50%^**	16%^**
18 mg, twice-daily	71%^***	40%^**	22%^**	18 mg, twice-daily	77%^**	45%^*	28%^**
Placebo	35%	17%	4%	24 mg, once-daily	82%^**	44%^*	25%^*
				Placebo	50%	20%	7%

*p<0.05, **p<0.01, ***p<0.001; last observation carried forward

Overall rates of discontinuation and serious adverse events were <5% and <3%, respectively, across both studies. Serious infections were reported in two patients, one on placebo and one on ABT-494. The most common adverse event was headache, which occurred in less than 5% of ABT-494 treated patients.

"These were well-designed studies across a broad dose range that allow us to understand the full potential of inhibiting this pathway," said Mark Genovese, M.D., professor of medicine, Stanford University Medical Center, Division of Immunology and Rheumatology. "The consistency of response and the overall safety profile of ABT-494 in these two patient populations offer the potential for significant benefit and support advancing this compound into Phase 3 studies. In particular, the TNF-IR population is increasing and represents those failing current standard of care. Anything we can do to better help these patients would represent an important advancement to the field."

BALANCE-I enrolled 276 patients, approximately 30 percent of whom had an inadequate response to two or more anti-TNF agents and 20 percent had an inadequate response to treatment with a non-TNF biologic. BALANCE-II enrolled 300 patients with an inadequate response to prior treatment with methotrexate.

"The levels of ACR response across the ABT-494 studies are impressive and warrant further investigation, particularly in treatment-refractory patients with the highest unmet need," said Joel Kremer, M.D., director of research, The Center for Rheumatology in Albany, New York and a clinical investigator on BALANCE-I.

About BALANCE-I study

BALANCE-I is a double-blind, placebo-controlled, dose-ranging Phase 2b study designed to evaluate the safety and efficacy of four doses of ABT-494 in adult patients with moderate to severely active rheumatoid arthritis who have had an inadequate response or intolerance to anti-TNF biologic therapy. Doses tested included 3, 6, 12, and 18 mg BID. The primary endpoint is the percentage of subjects achieving an ACR20 response after 12 weeks of treatment using an LOCF approach. Secondary objectives include safety and tolerability, as well as other efficacy assessments, such as the percentage of subjects achieving an ACR50 and ACR70 response.

About BALANCE-II study

BALANCE-II is a double-blind, placebo-controlled, dose-ranging Phase 2b study designed to evaluate the safety and efficacy of five doses of ABT-494 in adult patients with moderate to severely active rheumatoid arthritis who have had an inadequate response to prior treatment with methotrexate. Doses tested included 3, 6, 12, and 18 mg BID, and 24 mg QD. The primary endpoint is the percentage of subjects achieving an ACR20 response after 12 weeks of treatment using an LOCF approach. Secondary objectives include safety and tolerability, as well as other efficacy assessments such as the percentage of subjects achieving an ACR50 and ACR70 response.

About ABT-494

ABT-494 is an investigational oral agent that selectively inhibits JAK1, which plays an important role in the inflammatory process of rheumatoid arthritis. A Phase 2 trial of ABT-494 for the treatment of Crohn's disease is ongoing.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the likelihood that the transaction is consummated, the expected benefits of the transaction, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie